FDA approves Prestalia for treatment of hypertension

Therapeutic is the first fixed-dose combination of perindopril arginine and amlodipine

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CINCINNATI & BEND, Ore.—Symplmed Pharmaceuticals announced this week that the U.S. Food and Drug Administration had approved Prestalia (perindopril arginine and amlodipine) tablets, licensed from French pharma Servier, for the treatment of hypertension.
According to Symplmed, Prestalia is the first fixed-dose combination of these two medications; it is intended for patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.
“This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline to receive FDA approval,” said Erik Emerson, president and CEO of Symplmed. “With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension.”
“The burden of hypertension remains very high in all countries and the combination therapy is often the only treatment option for many patients,” said Dr. Isabelle Tupinon-Mathieu, Vice president of research and development and head of the Center for Therapeutic Innovation in Cardiology at Servier. “This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients.”
FDA approval of Prestalia was based on data from the 837-patient Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study reportedly demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.
“We now have another great combination of two drugs each with an evidence-based outcome history that are combined in a single pill,” said Dr. George Bakris, former president of the American Society of Hypertension and principal investigator for the PATH trial.
Symplmed plans to make Prestalia available to physicians and patients within the first quarter of 2015 through its hypertension management program, bpCareConnect. Powered by Symplmed’s DyrctAxess technology, bpCareConnect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships directly to the patient.
SOURCE: Symplmed Pharmaceuticals news release

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